Cefaly Technology issued the following announcement on October 13.
CEFALY Technology today announced that the U.S. Food and Drug Administration (FDA) has cleared the CEFALY DUAL medical device as an over-the-counter (OTC) product for the acute and preventative treatment of migraine headaches in adults (18 years and older). With the FDA's clearance, CEFALY DUAL becomes the first dual-purpose, external Trigeminal Nerve Stimulator (eTNS) device for migraine headaches available OTC in the United States.
Previously only available with a prescription in the U.S., OTC clearance of CEFALY DUAL will provide the nearly 39 million Americans living with migraine over-the-counter access to this convenient, non-drug and non-invasive treatment option.
"For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It's our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half," said Jennifer Trainor-McDermott, CEO with CEFALY Technology.
The submission in support of this OTC clearance of CEFALY DUAL was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device.
CEFALY DUAL can be purchased without a prescription at www.cefaly.com starting October 13, 2020.
CEFALY has rapidly become a global brand, widely recognized among the migraine community, which is estimated to be around 1 billion worldwide2. CEFALY DUAL is a non-invasive device placed on the forehead to modify pain sensation in the area research identifies as a center for migraine pain, the Trigeminal nerve. The device offers two distinct treatment options -- a 60-minute ACUTE setting that serves as an abortive treatment for pain relief at the onset of a migraine, which is clinically proven to stop or reduce migraine pain during an attack; and a 20-minute PREVENT setting for daily use to help prevent future episodes. The CEFALY device comes with a 60-day money back guarantee.
About CEFALY Technology
CEFALY Technology is a Belgium-based company, with US offices based in Darien, Connecticut, specializing in electronics for medical applications. CEFALY Technology's mission is to solve the persistent problem of migraine through advanced therapeutic innovations.
Original source can be found here.
